Name: 19th AGAH Annual Meeting 2010
Start: 2010-02-21T00:00:00+01:00
End: 2010-02-23T23:59:59+01:00
Location: Annual Meeting 2010

21. February 2010 - 23. February 2010
Annual Meeting 2010, Hamburg

Announcement

21 – 23 February 2010, Hamburg, Germany

To foster the creation of an association for applied human pharmacology, a group of human pharmacology experts working in Phase 1 Units in Industry and CROs organised a first conference in 1990 to exchange information and experience on how to perform human pharmacology trials according to the then newly established GCP principles and to enable faster drug development. This led to the foundation of AGAH (Association For Applied Human Pharmacology) which became incorporated in 1991, creating a lot of enthusiasm resulting every year in an interesting programme for the annual meetings. Thus, 2010 has marked the 20th AGAH Annual Meeting.

This was an excellent opportunity to critically review the progress made since, the lessons learned, as well as the potential to translate this knowledge into strategies and tools to successfully manage the forthcoming challenges in human pharmacology: drugs with new mechanisms of action, personalised therapies, higher pressure to achieve better predictability of a molecule’s suitability for further development, shorter development times and globalization of trial performance.

This conference gave the opportunity to critically review current and past approaches to drug development, learn about experiences and practical aspects of human pharmacology, discuss strategies and up-to-date tools for further improvement of clinical development in special populations, difficult pharmacokinetic conditions and an ever-changing regulatory environment.

Introduction

TWENTY YEARS OF APPLIED HUMAN PHARMACOLOGY IN CLINICAL DRUG DEVELOPMENT – LESSONS
LEARNED AND TRANSLATION TO FUTURE NEEDS
To foster the creation of an association for applied human pharmacology, a group of human pharmacology
experts working in Phase 1 Units in Industry and CROs
organised a first conference in 1990 to exchange information and experience on how to perform human
pharmacology trials according to the then newly established GCP principles and to enable faster drug development. This led to the foundation of AGAH (Association For Applied Human Pharmacology) which became
incorporated in 1991, creating a lot of enthusiasm resulting every year in an interesting programme for the
annual meetings. Thus, 2010 will mark the 20th AGAH
Annual Meeting.
This is an excellent opportunity to critically review the
progress made since, the lessons learned, as well as
the potential to translate this knowledge into strategies
and tools to successfully manage the forthcoming challenges in human pharmacology: drugs with new mechanisms of action, personalised therapies, higher
pressure to achieve better predictability of a molecule’s
suitability for further development, shorter development
times and globalisation of trial performance.
This conference will give you the opportunity to critically
review current and past approaches to drug development, learn about experiences and practical aspects of
human pharmacology, to discuss strategies and up-todate tools for further improvement of clinical development in special populations, difficult pharmacokinetic
conditions and an ever-changing regulatory environment.

Day 2, Monday, 22 February 2010

08:30

Registration

09:00

Opening remarks
Ingrid Klingmann, Brussels

Session 1:

PAST AND FUTURE CHALLENGES FOR APPLIED HUMAN PHARMACOLOGY

Chair

Kerstin Breithaupt-Grögler,
Jens Rengelshausen

9:10

Solved Problems and Unsolved Challenges in Applied Human Pharmacology
Hildegard Sourgens, Munich

9:40

The Changing Regulatory Requirements for Applied Human Pharmacology
Thomas Sudhop, Bonn

10:10

Applied Ethics and Societal Aspects in Applied Human Pharmacology
David Haerry, Bern

10:40

Health Economics in Early Clinical Drug Development
Clemens Troche, Schwäbisch Hall

11:10 – 11:40

Coffee Break

Session 2:

POX: POM, POP OR POC?

Chair:

Thomas Gramatté, Wolfgang Timmer

11:40

From PD Models to PoX: Changing Terms or Mindset?
Michael Zühlsdorf, Darmstadt

12:10

Lessons Learned (practical example)
Pierre Laurent-Puig, Paris

12:40

Phase I, Ib, IIa, IIb, etc. - Is this way of thinking still appropriate?
Robert Hermann, Radolfzell

13:10 – 14:30

Lunch

14:30 – 16:00

PARALLEL WORKSHOPS

WS 1

Cultural differences in GCP perception
Ilufredo (Fred) Tantoy, San Francisco

WS 2

Modern Strategies for the Development of Generic Drugs:
a) Locally Acting / Locally Applied Drug Products: A Playing Field for Human Pharmacologists?
Barbara Schug, Oberursel

WS 3

Modern Strategies for the Development of Generic Drugs:
b) Highly Variable Drugs: Sources of High Variability and Solutions to Overcome Problems in Bioequivalence Assessment“
Henning Blume, Oberursel/Germany,
Jan Welink, The Hague/The Netherlands

16:00 – 16:30

Coffee Break

Session 3:

FAST TRACK DEVELOPMENT –
HAS THE CONCEPT WORKED, AND WHEN
IS IT REALLY FEASIBLE?

Chair

Ulrich Feifel, Thomas Sudhop

16:30

The Regulatory Perspective:
What has Worked?
Birka Lehmann, Bonn

17:00

The Clinical Perspective:
Experiences and Tools for Fast Track Developments
Fritz Bühler, Basel

17:30

End of Sessions on Day 1

19:30

Conference Dinner

Day 3, Tuesday, 23 February 2010

Session 4:

SCIENCE-DRIVEN REGULATION VERSUS TICKBOX APPROACH:
APPLIED HUMAN PHARMACOLOGY IN SPECIAL POPULATIONS

Chair

Barbara Schug, Christian Hinze

9:00

Introductory Remarks from the Chair

9:15

Applied Human Pharmacology in Children:
From Past to Present
Matthias Schwab, Stuttgart

9:45

Paediatric Investigational Plan (PiP):
Clinical Impact vs. Effort?
Angelika Joos, Brussels

10:15

Renal Impairment: From Dettli to Guideline:
What Can We Learn?
Meinolf Wonnemann, Erfurt

10:45 - 11:15

Coffee Break

Session 5:

TOOLBOX IN CLINICAL PHARMACOLOGY – PAST, PRESENT AND FUTURE

Chair

Torben Thomsen, Michael Zühlsdorf

11:15

Today’s Value of Population Pharmacokinetics
Hans-Günter Schäfer, Biberach

11:45

Biomarker: Clinical Validation for Intended Use
Joop van Gerven, Leiden

12:15

The Value of Pharmacodynamic Models and Go / No Go Criteria During Clinical Drug Development
Georg Wensing, Wuppertal

12:45 – 13:45

Lunch Break

Session 6:

STRATEGIES FOR CLINICAL DRUG DEVELOPMENT IN THE FUTURE - APPLIED HUMAN PHARMACOLOGY 2.0

Chair

Fritz Bühler, Matthias Schwab

13:45

Key-note Speech
Adam Cohen, Leiden
Panel Discussion
F. Bühler, A. Cohen, M. Schwab, T. Sudhop,
J. van Gerven, G. Wensing

14:45

Closing Remarks
Torben Thomsen, Andernach

Downloads

Blume, H.

Blume H BE-HVD AGAH 2010 Einleitung1.pdf(100 kB)

Highly variable drugs: reasons for high variability and solutions to overcome BE problems

Bühler, F. R.

Buehler F.R. HH 2010.pdf(696 kB)

Fast Track Drug Development – The Clinical (Caleidoscopic) Perspective

Gerven, J. v.

Gerven J. v. HH 2010 01.pdf(1.4 MB)

Biomarker: Clinical Validation for Intended Use

Haerry, D. H.-U.

Haerry D. H.-U. HH 2010 01.pdf(0.9 MB)

Applied Ethics and Societal Aspects in Applied Human Pharmacology

Sourgens, H.

Sourgens H. HH 2010 01.pdf(3.2 MB)

Solved Problems and Unsolved Challenges in Applied Human Pharmacology

Sudhop, T.

Sudhop T. HH 2010 01.pdf(268 kB)

The Changing Regulatory Requirements for Applied Human Pharmacology

Tantoy, I.

Tantoy I. HH 2010 01.pdf(240 kB)

Cultural differences in GCP perception

Timmer, W.

Timmer W. HH 2010 01.pdf(830 kB)

Zielstellungen und Studienkonzepte früher Entwicklungsphasen

Wonnemann, M.

Wonnemann M. HH 2010 01.pdf(1.1 MB)

Renal Impairment – From Dettli to Guideline: What can we learn?

21. February 2010 - 23. February 2010

19th AGAH Annual Meeting 2010

Annual Meeting 2010

Hamburg
Deutschland

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Members of AGAH, CPI, AHPPI, BAPU	340 EUR
Non-members	400 EUR
Junior scientists	250 EUR
Day ticket	200 EUR